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Vyepti
Eintrag öffnenVyepti · 4.1 Therapeutic indications · 1
Eintrag öffnenVyepti · 4.3 Contraindications · 1
Eintrag öffnenVyepti · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Eintrag öffnenVyepti · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenVyepti · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenVyepti · 4.5 · Eptinezumab is not metabolized by cytochrome P450 enzymes. Therefore, interactions by eptinezumab with concomi
Eintrag öffnenVyepti · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenVyepti · 4.8 Undesirable effects · 1
Eintrag öffnenVyepti · 4.8 · 5 Fatigue Approximately 3% of patients on eptinezumab and 2% of patients on placebo in the placebo- controlled
Eintrag öffnenVyepti · 4.8 · Adverse reactions from clinical trials and post-marketing experience (table 1) are classified by MedDRA system
Eintrag öffnenVyepti · 4.8 · Description of selected adverse reactions
Eintrag öffnenVyepti · 4.8 · Hypersensitivity and infusion-related reactions Serious hypersensitivity reactions, including anaphylactic rea
Eintrag öffnenVyepti · 4.8 · Immunogenicity In the pivotal placebo-controlled studies with treatment durations ranging from 3 to 12 months,
Eintrag öffnenVyepti · 4.8 · In the clinical studies, eptinezumab trough plasma concentrations appeared lower in patients who developed ant
Eintrag öffnenVyepti · 4.8 · In the long-term, repeat dose studies with treatment durations of at least 1 year, the incidence of ADAs and N
Eintrag öffnenVyepti · 4.8 · Over 5 900 patients have been treated with VYEPTI in clinical studies. Of these, approximately 3 000 patients
Eintrag öffnenVyepti · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenVyepti · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenVyepti · 4.8 · Summary of the safety profile
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